Pharmaceutical Technology

SEPTEMBER 15, 2022

Contract marketing companies offer various marketing services that connect suitable strategies with customers at different points in the product lifecycle, helping to increase the customer base and thus revenue. Finding the top API chemical companies in contract marketing.

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Crucial Data Soutions

DECEMBER 15, 2020

Someday, clinical and post-market research will be 100 percent remote. A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The research team accomplishes a rapid trial start-up with the platform’s efficient study design tools. It’s winter 2020 and COVID-19 is in full swing.

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Pharmaceutical Technology

OCTOBER 26, 2022

The biotherapeutics market is rapidly growing, with 2021 seeing the highest-ever cell and gene therapy approval number. The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. The future of cell and gene therapies. Collaboration and integrated manufacturing.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Pharma Mirror

FEBRUARY 18, 2022

From research to clinical trials, to go-to-market, drug makers are constantly seeking out new drug technologies and approaches to treat everyday illnesses and to end global pandemics. But the vials and containers that deliver these drugs haven’t evolved at nearly the same rate.

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Pharmaceutical Technology

SEPTEMBER 8, 2022

Find the leading API biologics companies in contract marketing. Pharmaceutical Technology has listed some of the top API biologics companies in contract marketing based on our intel, insights and decades-long experience in the sector.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Advarra

DECEMBER 17, 2024

For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

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Delveinsight

JULY 26, 2021

However, antibiotics are the only available treatment options in the Uncomplicated Urinary Tract Infections market to cater to such a large patient pool. Some of the most commonly prescribed antibiotics in the Uncomplicated Urinary Tract Infection therapy market include the combination drug trimethoprim and sulfamethoxazole, trimethoprim, ?-lactams,

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Pharmaceutical Technology

JANUARY 24, 2023

Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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XTalks

NOVEMBER 5, 2024

per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024. Polyrizon Ltd., million in gross proceeds. The IPO, priced at $4.38 Polyrizon Ltd.

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World of DTC Marketing

NOVEMBER 27, 2020

Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.

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World of DTC Marketing

JUNE 10, 2021

If the message is promotional, there is a high likelihood you will get a poor response, but if the message contains important updates, it is more likely to be read. On the other hand, we did make a thought elder, who worked on clinical trials of a cancer drug, to take questions from other physicians about those clinical trials.

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Doctors Doctor Clinical Trials Clinical Trials 143

World of DTC Marketing

FEBRUARY 9, 2021

In clinical trials, how many people experienced a listed side effect? Email is still a great digital marketing tool, and our audiences felt that if the email contained updated health information and tips for living with certain health problems, they would open and read it. First impressions are 94% design-related.

Drugs 180

Drugs Pharma Production Doctor Doctors 180

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

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XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. The FDA’s approval of Posluma was based on two Phase III clinical trials, LIGHTHOUSE and SPOTLIGHT. billion by 2030, according to a report by Global Market Insights.

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Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

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The Pharma Data

JANUARY 10, 2021

Each of the first three dose cohorts contain up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. This release contains forward-looking statements. For additional information please visit www.aslanpharma.com.

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pharmaphorum

MAY 24, 2021

This article appears in out digital magazine Deep Dive: Market Access 2021. Having gone from being an innovation buzzword to becoming a core part of drug assessment processes it offers health technology assessment (HTA) bodies a way to assess the value and impact of drugs outside of an artificial clinical trial setting.

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The Pharma Data

JANUARY 17, 2021

The treatment is based on the Grifols immunoglobulin Gamunex®-C, and contains anti-SARS-COV-2 polyclonal antibodies from plasma donors who have recovered from COVID-19. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway. BARCELONA, Spain , Jan. and on the U.S.

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The Pharma Data

OCTOBER 19, 2020

In addition to its manufacturing efforts, the Company has also made progress in its clinical trial preparations. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. About CNS Pharmaceuticals, Inc. .

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Pharma Marketing Network

FEBRUARY 5, 2025

Table of Contents Sr# Headings 1 Understanding Pharmaceutical Market Access 2 Challenges in Pharmaceutical Market Access 3 Key Strategies for Market Access Success 4 Emerging Trends Shaping Market Access Understanding Pharmaceutical Market Access Bringing a new drug to market is only part of the battle.

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Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.

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Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Pfizer

JANUARY 27, 2023

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Disclosure Notice The information contained in this statement is as of January 27, 2023.

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The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

DECEMBER 14, 2022

For years, Jazz Pharmaceuticals has dominated the market in treating narcolepsy with cataplexy. Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. Monopoly money.

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pharmaphorum

OCTOBER 2, 2020

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

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Regulation Vaccine Vaccination Protein 105

Camargo

JUNE 4, 2021

The new product, Zynrelef, is the first modified-release formulation for pain that will be labeled as extended-release; in the three Phase 3 clinical trials, it demonstrated pain reduction through 72 hours. FDA-Issued Guidances Offer Clarification on PREA, QIDP Designation, Post-Marketing Requirements, and More.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . 21 CFR 312.3(b)

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pharmaphorum

NOVEMBER 28, 2021

The drug is – an oral spray containing cannabinoids THC and CBD which is already licensed and sold by other companies in some markets for neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis. Jazz acquired rights to Sativex when it completed its $7.2

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The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Restrictions on the supply of codeine-containing products. The main focus of this post is to introduce the most common over the counter codeine-containing products in the UK and review their codeine content.

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Advarra

MARCH 10, 2023

Red blood cells contain hemoglobin, a protein that carries oxygen. hindering progress on SCD – there is also a lack of clinical trials and research. Diversity in Clinical Trials and SCD As many clinical trials in the U.S.

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Roots Analysis

FEBRUARY 28, 2024

Cell Therapy pipeline update, Talaris Therapeutics , a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY , announced the initiation of FREEDOM-1 ( NCT03995901 ), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

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pharmaphorum

AUGUST 31, 2021

Many of our innovative life sciences partners pre-socialise their ECA strategy in early discussions with the FDA before finalising the clinical trial to get feedback on the approach from the ultimate decision maker. Myth 3: RWD is too imperfect to be used to as a comparator arm to a clinical trial.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Pre-market requirements include those for obtaining marketing authorization, including 510(k) clearance (21 C.F.R.

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